First product launch following acquisition of Organon BioSciences
KENILWORTH, N.J., Sept. 10 /PRNewswire-FirstCall/ -- Schering-Plough
Corporation (NYSE: SGP) today announced that the European launch of
BRIDION(R) (sugammadex) injection has begun with its introduction this week
in Sweden, and that the product is expected to be available soon in the
United Kingdom and Germany, with several other European markets to follow
by the end of the year and in early 2009.
"The introduction of BRIDION in Europe represents an important advance
for anesthesiologists and the patients they care for during surgery, and is
a significant achievement for Schering-Plough, as we bring our first
product to market since combining with Organon BioSciences," said Fred
Hassan, chairman and CEO. "BRIDION has the potential to transform the
practice of anesthesia, and it is a tremendous example of our company's
innovation and leadership in this field."
BRIDION was discovered by researchers at the company's facility in
Newhouse, Scotland, and was approved for marketing by the European
Commission on July 29. It is the first and only selective relaxant binding
agent (SRBA) and represents the first major pharmaceutical advance in the
field of anesthesia in two decades. BRIDION is indicated for routine
reversal of the commonly used muscle relaxants rocuronium or vecuronium and
for immediate reversal of rocuronium in adults, and for routine reversal
following rocuronium in children and adolescents (2-17 years of age).
Rocuronium and vecuronium are given as part of general anesthesia to relax
a patient's muscles during surgery.
BRIDION works in an entirely novel way by encapsulating the muscle
relaxant molecule and rendering it inactive. It was specifically designed
to reverse within minutes both moderate and deep muscle relaxation induced
by rocuronium or vecuronium during general anesthesia. As a result, BRIDION
can give anesthesiologists greater control in managing the depth of muscle
relaxation through to the end of a surgical procedure. This may help
improve surgical conditions in the millions of procedures where these
agents are used.
A muscle relaxant plays several critical roles in general anesthesia.
Anesthesiologists use muscle relaxation to improve surgical conditions and
to facilitate intubation and mechanical ventilation. Reversal agents
reverse the effects of muscle relaxants, enabling patients to regain normal
muscle function sooner and breathe on their own. Current reversal agents
are slow and are associated with certain undesirable side effects,
including cardiac rhythm disturbances and gastrointestinal and pulmonary
side effects.
Schering-Plough acquired BRIDION (sugammadex) through its combination
with Organon BioSciences in November 2007.
Important Safety Information About BRIDION
BRIDION (sugammadex) should only be administered by or under the
supervision of an anesthesiologist. The use of an appropriate neuromuscular
monitoring technique is recommended to monitor the recovery of
neuromuscular blockade. The use of sugammadex in patients with severe renal
impairment is not recommended.
In clinical trials, the most commonly reported adverse reaction was
metal or bitter taste. Also commonly reported were anesthetic
complications, indicative of the restoration of neuromuscular function,
including movement of a limb or the body or coughing during the anesthetic
procedure or during surgery, grimacing, or suckling on the endotracheal
tube. In a few individuals, allergic-like reactions (i.e. flushing,
erythematous rash) following sugammadex were reported.
For full Prescribing Information please go to http://www.bridion.com.
About Schering-Plough
Schering-Plough is an innovation-driven, science-centered global health
care company. Through its own biopharmaceutical research and collaborations
with partners, Schering-Plough creates therapies that help save and improve
lives around the world. The company applies its research-and-development
platform to human prescription and consumer products as well as to animal
health products. Schering-Plough's vision is to "Earn Trust, Every Day"
with the doctors, patients, customers and other stakeholders served by its
colleagues around the world. The company is based in Kenilworth, N.J., USA,
and its Web site is http://www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press
release includes certain "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995, including statements
relating to the plans for, the potential of and the potential market for
BRIDION. Forward-looking statements relate to expectations or forecasts of
future events. Schering-Plough does not assume the obligation to update any
forward-looking statement. Many factors could cause actual results to
differ materially from Schering-Plough's forward-looking statements,
including market forces, economic factors, product availability, patent and
other intellectual property protection, current and future branded, generic
or over-the-counter competition, the regulatory process, and any
developments following regulatory approval, among other uncertainties. For
further details about these and other factors that may impact the
forward-looking statements, see Schering-Plough's Securities and Exchange
Commission filings, including Part II, Item 1A, "Risk Factors" in the
company's second quarter 2008 10-Q.
SOURCE Schering-Plough
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Related links:
http://www.schering-plough.com
http://www.bridion.com
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